IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies
Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies

IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies MD 7.6.4: Appraise certified manufacturers' public information and use it during assessment

What does MD 7.6.4 require?

Before or during an assessment the team appraises publicly available information, including websites, that a sample of the manufacturers certified by the body publishes to advertise or promote medical devices within the technical categories covered by the accredited ISO 13485 certificates, and uses that appraisal to judge whether what audit reports and certificates record about the devices' technologies, purposes and risk classes matches what the public information shows.

Maintained by Gerard Blokdyk

Other controls in Clause 7: Process requirements – IAF MD 8 / Global ACI TECH-3-006 Application of ISO/IEC 17011 for Accreditation of ISO 13485 Certification Bodies

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